Device makers agree to pay double for better FDA performance

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Roll of Money - 13.41 Kb

Manufacturers of medical devices have agreed to pay substantially higher fees to the FDA in exchange for speedier and more predictable reviews, according to a news release from the agency. The deal, which needs to be approved by Congress, would double the dollars kicked in by industry—to $595 million over the next five years, up from $295 million over the past five years, according to multiple sources.

More than a year in the making, the agreement “strikes a careful balance between what industry agreed to pay and what the FDA can accomplish” with the amount of funding proposed, the agency said.

FDA said the increased revenue will allow it to staff up with 200 new hires of scientists and other device-review workers, paving the way to a reduction in average total review times. It also pledged greater accountability, predictability and transparency through a more structured presubmission process and better communications between FDA and applicants.

Among the industry associations that agreed to the doubled fees were the Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA) and the Medical Imaging and Technology Alliance (MITA).

“I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees,” said FDA Commissioner Margaret A. Hamburg, MD. “Reauthorization of this important program is an essential component for advancing medical device innovation.”

Industry representatives were equally quick to voice their enthusiasm for the agreement.

Once the final details of the pact are completed, FDA will develop a package of proposed recommendations and open them for public comment. The package will then go to Congress. Dates have yet to be determined, but the current fee structure is set to expire Sept. 30.